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15 November 2017, 12:54 | Rodolfo Wallace
The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet. Proteus Digital Health
The US regulator has approved the first digital pill with embedded sensors to track whether patients are taking their medications correctly, marking a significant step forward in the development of healthcare and technology services. The medication must also be dispensed with a patient Medication Guide with information about the drug's uses and risks.
Of the many hurdles drugmakers face - mastering complex science, navigating regulations, crafting successful marketing campaigns - patient adherence remains one of the most hard to clear.
"When patients don't adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly", Dr. William Shrank, chief medical officer of the health plan division at the University of Pittsburgh Medical Center, told the Times. In September, the FDAapproved the first mobile app to treat certain substance use disorders, developed by the Boston company Pear Therapeutics. The agency says the digitally enhanced medication "works by sending a message from the pill's sensor to a wearable patch".
Abilify MyCite's future isn't certain, however. Since digital Abilify hasn't been shown to improve patient compliance, it should not be used to track drug ingestion in real-time or during an emergency, the FDA said. The sensor in Ability MyCite syncs with a smart phone and sends an alert when the medication is ingested via a patch that is worn on the surface of the skin. Monday's hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out. The Japanese pharma reported Abilify sales of ¥53.6 billion (about $479 million) for the first nine months of 2017, down 30% from the same period in 2016.
Though it's not approved for elderly patients diagnosed with dementia-related psychosis, the new technology still comes with a Boxed Warning alerting healthcare professionals that elderly patients diagnosed with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The information can also be accessed by caregivers and physicians through a web-based portal, but patients have to grant access.
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